Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)

A Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty

This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty

This study used Active and placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery

Inclusion Criteria:

• Able to provide written informed consent
• Age 18 to 80 years, inclusive
• BMI 18-32 kg/m²
• ASA physical status I-II
• Scheduled for elective unilateral total hip arthroplasty under general anesthesia
• Able to understand study procedures and pain rating scales

Exclusion Criteria:

• Hypersensitivity to TRD205, celecoxib, or study-related medications
• Use of prohibited analgesics, sedatives, CYP3A4 inhibitors/inducers, or analgesic herbs within specified washout periods
• Inability to take oral medications postoperatively
• Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month
• Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip
• Clinically significant hemodynamic instability or cardiac arrhythmia
• Severe hepatic, renal, cardiovascular, or metabolic disease
• History of NSAID-induced asthma, active peptic ulcer disease
• Drug or alcohol abuse within 1 year
• Pregnancy, breastfeeding, or lack of effective contraception
• Participation in another interventional clinical trial within 3 months